hypersensitivity to cgrp as a predictive biomarker of migraine prevention with erenumab

Conditions: Migraine

Summary: to explore the relationship between clinical response to erenumab and response to intravenous infusion of calcitonin gene-related peptide in individuals with migraine.

this is a single-center, non-randomized, single-arm, open-label study, in which adults with episodic or chronic migraine will receive intravenous infusion with calcitonin gene-related peptide and subsequently be treated with erenumab. the study will consist of the following elements: * provocation phase (1 experimental day with intravenous infusion of calcitonin gene-related peptide) * screening/baseline phase (4 weeks) * open-label treatment phase (24 weeks)

Eligibility criteria:
inclusion criteria: * age ≥ 18 years of age upon entry into screening * history of migraine with or without aura for ≥ 12 months according to the international classification of headache disorders 3rd edition (ichd-3) criteria * ≥ 4 headache days that meet criteria as migraine days per month on average across the 3 months before screening * subject has provided informed consent prior to initiation of any study-specific activities/procedures. * must have demonstrated greater than or equal to 75% compliance in headache diary usage during the 4-week run-period prior to day 1 of the open-label treatment phase. exclusion criteria: * \> 50 years of age at migraine onset * history of cluster headache or hemiplegic migraine * inability to differentiate migraine from other headaches * the subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior * history or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion * previously received erenumab (aimovig) * received anti-cgrp monoclonal antibody within 3 months prior to the cgrp-infusion * currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives since ending treatment on another investigational device or drug study(ies). other investigational procedures while participating in this study are excluded. * female subjects of childbearing potential with a positive pregnancy test during any study visit * female subject is pregnant or breastfeeding or planning to become pregnant during the study * evidence of current pregnancy or breastfeeding * female subject of childbearing potential unwilling to use an acceptable method of effective contraception * hypertension on the experimental day defined as systolic blood pressure ≥ 150mmhg or diastolic blood pressure ≥ 100mmhg * hypotension on the experimental day defined as systolic blood pressure \< 90mmhg or diastolic blood pressure \< 50mmhg * any headache (including migraine) within 24 hours prior to the start of the cgrp-infusion * intake of any analgesics or migraine-specific medications within 24 hours prior to the start of the cgrp-infusion * subject likely to not be available to complete all protocol-required study visits or procedures, and/or comply with all required study procedures to the best of the subject and study investigator's knowledge